Tissue fixation devices and a transoral endoscopic gastroesophageal flap valve restoration device and assembly using same

ABSTRACT

Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together. The fasteners include a first member, a second member, and a connecting member extending between the first and second members. The first and second members are substantially parallel to each other. The fasteners may be deployed in limited spaces and in various applications including the restoration of a gastroesophageal flap valve.

FIELD OF THE INVENTION

The present invention generally relates to tissue fixation devices, andmore particularly to devices for treating gastroesophageal refluxdisease using the same. The present invention more particularly relatesto such tissue fixation devices which may be used in surgicalenvironments and which are self-deploying.

BACKGROUND

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from splashing into theesophagus. The splashing is known as gastroesophageal reflux. Thestomach acid is designed to digest meat, and will digest esophagealtissue when persistently splashed into the esophagus.

A principal reason for regurgitation associated with GERD is themechanical failure of a deteriorated gastroesophageal flap to close andseal against high pressure in the stomach. Due to reasons includinglifestyle, a Grade I normal gastroesophageal flap may deteriorate into amalfunctioning Grade III or absent valve Grade IV gastroesophageal flap.With a deteriorated gastroesophageal flap, the stomach contents are morelikely to be regurgitated into the esophagus, the mouth, and even thelungs. The regurgitation is referred to as “heartburn” because the mostcommon symptom is a burning discomfort in the chest under thebreastbone. Burning discomfort in the chest and regurgitation (burpingup) of sour-tasting gastric juice into the mouth are classic symptoms ofgastroesophageal reflux disease (GERD). When stomach acid isregurgitated into the esophagus, it is usually cleared quickly byesophageal contractions. Heartburn (backwashing of stomach acid and bileonto the esophagus) results when stomach acid is frequently regurgitatedinto the esophagus and the esophageal wall is inflamed.

Complications develop for some people who have GERD. Esophagitis(inflammation of the esophagus) with erosions and ulcerations (breaks inthe lining of the esophagus) can occur from repeated and prolonged acidexposure. If these breaks are deep, bleeding or scarring of theesophagus with formation of a stricture (narrowing of the esophagus) canoccur. If the esophagus narrows significantly, then food sticks in theesophagus and the symptom is known as dysphagia. GERD has been shown tobe one of the most important risk factors for the development ofesophageal adenocarcinoma. In a subset of people who have severe GERD,if acid exposure continues, the injured squamous lining is replaced by aprecancerous lining (called Barrett's Esophagus) in which a cancerousesophageal adenocarcinoma can develop.

Other complications of GERD may not appear to be related to esophagealdisease at all. Some people with GERD may develop recurrent pneumonia(lung infection), asthma (wheezing), or a chronic cough from acidbacking up into the esophagus and all the way up through the upperesophageal sphincter into the lungs. In many instances, this occurs atnight, while the person is in a supine position and sleeping.Occasionally, a person with severe GERD will be awakened from sleep witha choking sensation. Hoarseness can also occur due to acid reaching thevocal cords, causing a chronic inflammation or injury.

GERD never improves without intervention. Life style changes combinedwith both medical and surgical treatments exist for GERD. Medicaltherapies include antacids and proton pump inhibitors. However, themedical therapies only mask the reflux. Patients still get reflux andperhaps emphysema because of particles refluxed into the lungs.Barrett's esophagus results in about 10% of the GERD cases. Theesophageal epithelium changes into tissue that tends to become cancerousfrom repeated acid washing despite the medication.

Several open laparotomy and laproscopic surgical procedures areavailable for treating GERD. One surgical approach is the Nissenfundoplication. The Nissen approach typically involves a 360-degree wrapof the fundus around the gastroesophageal junction. The procedure has ahigh incidence of postoperative complications. The Nissen approachcreates a 360-degree moveable flap without a fixed portion. Hence,Nissen does not restore the normal movable flap. The patient cannot burpbecause the fundus was used to make the repair, and may frequentlyexperience dysphagia. Another surgical approach to treating GERD is theBelsey Mark IV (Belsey) fundoplication. The Belsey procedure involvescreating a valve by suturing a portion of the stomach to an anteriorsurface of the esophagus. It reduces some of the postoperativecomplications encountered with the Nissen fundoplication, but still doesnot restore the normal movable flap. None of these procedures fullyrestores the normal anatomical anatomy or produces a normallyfunctioning gastroesophageal junction. Another surgical approach is theHill repair. In the Hill repair, the gastroesophageal junction isanchored to the posterior abdominal areas, and a 180-degree valve iscreated by a system of sutures. The Hill procedure restores the moveableflap, the cardiac notch and the Angle of His. However, all of thesesurgical procedures are very invasive, regardless of whether done as alaproscopic or an open procedure.

New, less surgically invasive approaches to treating GERD involvetransoral endoscopic procedures. One procedure contemplates a machinedevice with robotic arms that is inserted transorally into the stomach.While observing through an endoscope, an endoscopist guides the machinewithin the stomach to engage a portion of the fundus with acorkscrew-like device on one arm. The arm then pulls on the engagedportion to create a fold of tissue or radial plication at thegastroesophageal junction. Another arm of the machine pinches the excesstissue together and fastens the excess tissue with one pre-tied implant.This procedure does not restore normal anatomy. The fold created doesnot have anything in common with a valve. In fact, the direction of theradial fold prevents the fold or plication from acting as a flap of avalve.

Another transoral procedure contemplates making a fold of fundus tissuenear the deteriorated gastroesophageal flap to recreate the loweresophageal sphincter (LES). The procedure requires placing multipleU-shaped tissue clips around the folded fundus to hold it in shape andin place.

This and the previously discussed procedure are both highly dependent onthe skill, experience, aggressiveness, and courage of the endoscopist.In addition, these and other procedures may involve esophageal tissue inthe repair. Esophageal tissue is fragile and weak. Involvement ofesophageal tissue in the repair of a gastroesophageal flap valve posesunnecessary risks to the patient.

A new and improved apparatus and method for restoration of agastroesophageal flap valve is fully disclosed in copending U.S.application Ser. No. 10/150,740, filed May 17, 2002, for TRANSORALENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE, ASSEMBLY,SYSTEM AND METHOD, is assigned to the assignee of this invention, and isincorporated herein by reference. That apparatus and method provides atransoral endoscopic gastroesophageal flap valve restoration. Alongitudinal member arranged for transoral placement into a stomachcarries a tissue shaper that non-invasively grips and shapes stomachtissue. A tissue fixation device is then deployed to maintain the shapedstomach tissue in a shape approximating a gastroesophageal flap.

Whenever tissue is to be maintained in a shape as, for example, in theimproved assembly last mentioned above, it is necessary to fasten atleast two layers of tissue together. In applications such asgastroesophageal flap valve restoration, there is very limited room tomaneuver a fastener deployment device. For example, this and othermedical fastening applications provide confined working channels andspaces and often must be fed through an endoscope to permitvisualization or other small lumen guide catheters to the place wherethe fasteners are to be deployed. To make matters worse, multiplefasteners may also be required. Hence, with current fasteners anddeployment arrangements, it is often difficult to direct a singlefastener to its intended location, let alone a number of such fasteners.

Once the fastening site is located, the fasteners employed must be trulyable to securely maintain the tissue. Also, quite obviously, thefasteners are preferably deployable in the tissue in a manner which doesnot unduly traumatize the tissue.

SUMMARY

The present invention provides a fastener for use in a mammalian body,comprising a first member, a second member, the first and second membershaving first and second ends, and a connecting member fixed to each ofthe first and second members intermediate the first and second ends andextending between the first and second members. The first and secondmembers are separated by the connecting member, and one of the first andsecond members has a longitudinal axis and a through channel along theaxis arranged to be slidingly received on a tissue piercing deploymentwire.

The connecting member may be flexible permitting another one of thefirst and second members to be next to the one of the first and secondmembers when the one of the first and second members is on the tissuepiercing deployment wire.

One end of the one of the first and second members may include a pointedtip. The pointed tip may be conical or comprise a tapered sectionedportion.

Both the first and second members may include a longitudinal axis and athrough channel along each respective axis. One end of both the firstand second members may include a pointed tip. The pointed tips may pointin opposite directions.

The through channels are arranged to be slidingly received by the tissuepiercing deployment wire. The connecting member may be flexiblepermitting the first and second members to be in line with each other onthe tissue piercing deployment wire.

The first member, second member, and the connecting member may all beformed of plastic material and in one piece or multiple pieces.

The connecting member of the fastener may be formed of plastic elasticmaterial. Alternatively, the connecting member may be formed of aplastic, permanently deformable material. The plastic material mayinclude a color pigment contrasting with body tissue color to enablevisualization of the fastener with an endoscope.

The connecting member has a vertical dimension and a horizontaldimension transverse to the vertical dimension, and the horizontaldimension may be substantially less than the vertical dimensionrendering the connecting member readily bendable in a horizontal plane.At least one of the first and second members may include a plurality oflongitudinally spaced vertical slots rendering the at least one of thefirst and second members flexible in a direction opposite the slots butstiff in a direction of the slots. The device may comprise a pluralityof the connecting members.

The fastener may alternatively be formed of metal and particularly ashape memory material. The first and second members may then beself-deployable. One of the first and second members may beself-deployable while on the tissue piercing deployment wire.

At least one of the first and second members may be self-deployable uponremoval from the tissue piercing deployment wire. The at least one ofthe first and second members is preferably distal to another one of thefirst and second members and the another one of the first and secondmembers may include a crimp that provides a controlled resistance tomovement on the tissue piercing deployment wire.

The first member, the second member, and the connecting member may beintegrally formed from a same tubular member stock. The connectingmember may comprise a strip of the tubular member formed by a pair oflongitudinal substantially parallel, substantially coextensive cutswithin the tubular member and the first and second members may be formedby a substantially transverse circumferential cut between thesubstantially parallel coextensive cuts.

The tubular member may have first and second opposed ends and thesubstantially parallel substantially coextensive cuts may begin spacedfrom the first end and terminate spaced from the second end. The firstand second members may then be tubular member sections between thecircumferential cut and the tubular member first and second ends. Anelongated notch may extend from one of the ends of the tubular member,substantially diametrically opposite and juxtaposed to a portion of theconnecting member strip.

The invention further provides a fastener assembly for use in amammalian body. The assembly includes a fastener including a firstmember, a second member, the first and second members having first andsecond ends, and a connecting member fixed to each of the first andsecond members intermediate the first and second ends and extendingbetween the first and second members. The first and second members areseparated by the connecting member, and one of the first and secondmembers may have a longitudinal axis and a through channel along theaxis. The assembly further includes a deployment wire that slidinglyreceives the through channel of the one of the first and second membersand pierces into the tissue, and a pusher that pushes the one of firstand second members into the tissue while on the deployment wire.

The pusher is preferably also arranged to be slidingly received on thedeployment wire. The connecting member of the fastener may be flexible,and the assembly may further comprise a guide tube extending over thedeployment wire and the fastener. The other one of the first and secondmembers may be disposed next to the one of the first and second memberswithin the guide tube.

One end of the one of the first and second members of the fastener mayfurther include a pointed tip. The pointed tip may comprise a truncatedcone. Alternatively, the pointed tip may comprise a sectioned portion.Either one or both of the first and second members may include alongitudinal axis and a through channel along each respective axis. Thethrough channels of the first and second members may be arranged to beslidingly received by the tissue piercing deployment wire and theconnecting member is preferably flexible permitting the first and secondmembers to be in line with each other on the tissue piercing deploymentwire. The guide tube may then extend over the deployment wire and thefastener.

The invention still further provides a tissue fixation assembly. Theassembly includes a fastener and a pair of hingedly coupled first andsecond arms for receiving the tissue therebetween. The first armincludes a fastener director that directs the fastener into the tissueand the second arm includes an opening permitting the fastener to bedriven through the tissue while being held between the first and secondarms. The second arm is preferably a frame structure.

The assembly may further comprise a tissue gripper that grips the tissueand pulls the tissue into and between the first and second arms. Thefirst arm may have a tissue engaging surface and the fastener directormay include a channel communicating with the tissue engaging surfacethrough which the fastener passes into the tissue.

The fastener director may include a plurality of the channels to directa like plurality of fasteners into the tissue. The assembly may furthercomprise a fastener deployment wire that guides the fastener through oneof the channels and into the tissue.

The fastener of the assembly may comprise a first member, a secondmember, the first and second members having first and second ends, and aconnecting member fixed to each of the first and second membersintermediate the first and second ends and extending between the firstand second members. The first and second members are separated by theconnecting member when the fastener is deployed. One of the first andsecond members preferably has a longitudinal axis and a through channelalong the axis arranged to be slidingly received on the fastenerdeployment wire.

The invention still further provides a transoral gastroesophageal flapvalve restoration device. The device includes a longitudinal member, aportion of which is arranged for transoral placement into a stomach, afastener, and a tissue shaper carried on the longitudinal member. Thetissue shaper shapes stomach tissue into a shape and includes a pair ofhingedly coupled first and second arms for receiving the stomach tissuetherebetween, the first arm including a fastener director that directsthe fastener into the stomach tissue and the second arm including anopening permitting the fastener to be driven through the stomach tissuewhile being held between the first and second arms.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like referenced numerals identify like elements, and wherein:

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract from a lower portion of the esophagusto the duodenum;

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap of the gastroesophageal flap valve (in dashedlines) and a Grade III reflux appearance gastroesophageal flap of thegastroesophageal flap valve (in solid lines);

FIG. 3 is a perspective view of a fastener according to an embodiment ofthe invention;

FIG. 4 is a perspective view of another fastener according to anembodiment of the invention;

FIG. 5 is a perspective view with portions cut away of a fastenerassembly according to an embodiment of the invention in an early stageof deploying a fastener embodiment of the invention;

FIG. 6 is a perspective view of the assembly of FIG. 5 shown with thefastener being driven in the tissue layers to be fastened;

FIG. 7 is a perspective view of the assembly of FIG. 5 shown with thefastener extending through the tissue layers to be fastened;

FIG. 8 is a perspective view of the assembly of FIG. 5 shown with thefastener initially deployed;

FIG. 9 is a perspective view showing the fastener of the assembly ofFIG. 5 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 10 is a perspective view with portions cut away of another fastenerdeployment assembly according to an embodiment of the invention in anearly stage of deploying another fastener embodiment of the invention;

FIG. 11 is a perspective view with portions cut away of another fastenerdeployment assembly according to an embodiment of the invention in anearly stage of deploying another fastener embodiment of the invention;

FIG. 12 is a perspective view showing the fastener of the assembly ofFIG. 11 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 13A is a perspective view, to an enlarged scale, of the fastener ofFIG. 13;

FIG. 14 is a perspective view of the assembly of FIG. 13 shown with thefastener being driven in the tissue layers to be fastened;

FIG. 15 is a perspective view of the assembly of FIG. 13 shown with thefastener extending through the tissue layers to be fastened andpartially deployed;

FIG. 16 is a perspective view of the assembly of FIG. 13 shown with thefastener initially fully deployed;

FIG. 17 is a perspective view showing the fastener of the assembly ofFIG. 13 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 18 is a perspective view with portions cut away of another fastenerdeployment assembly according to an embodiment of the invention in anearly stage of deploying the fastener of FIG. 13;

FIG. 19 is a perspective view of the assembly of FIG. 18 shown with thedeployment wire driven through the tissue layers to be fastened;

FIG. 20 is a perspective view of the assembly of FIG. 18 shown as inFIG. 19 but with the proximal end of the fastener being released into adeployed configuration before the fastener is driven into the tissuelayers to be fastened;

FIG. 21 is a perspective view of the assembly of FIG. 18 shown with thefastener extending through the tissue layers to be fastened;

FIG. 22 is a perspective view of the assembly of FIG. 18 shown with thefastener initially deployed;

FIG. 23 is a perspective view showing the fastener of the assembly ofFIG. 18 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 24 is a perspective view of the fastener of FIG. 13 showing thefastener embedded within a layer of tissue;

FIG. 25 is a perspective view with portions cut away of a fastenerassembly according to an embodiment of the invention in an early stageof deploying a still further fastener embodiment of the invention;

FIG. 26 is a side view, partly in cross-section of another fastenerembodiment of the invention which provides resistance to relativemovement between the fastener and a deployment wire;

FIG. 27 is a perspective side view, partly in phantom of agastroesophageal flap valve restoration device embodying the presentinvention shown in an initial state before use;

FIG. 28 is another perspective side view, partly in phantom of thegastroesophageal flap valve restoration device of FIG. 27 embodying thepresent invention shown in an intermediate state during use;

FIG. 29 is a side view, partly in cross-section of the gastroesophagealflap valve restoration device of FIG. 27 shown forming agastroesophageal flap valve from stomach tissue prior to delivery of afastener to maintain the flap valve.

FIG. 30 is a perspective view of another fastener embodiment of thepresent invention;

FIG. 31 is a top plan view of the fastener of FIG. 30;

FIG. 32 is a perspective view of still another fastener embodiment ofthe present invention, and;

FIG. 33 is a top plan view of the fastener of FIG.32.

DETAILED DESCRIPTION

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to the duodenum 42. The stomach 43 is characterized by thegreater curvature 44 on the anatomical left side and the lessercurvature 45 on the anatomical right side. The tissue of the outersurfaces of those curvatures is referred to in the art as serosa tissue.As will be seen subsequently, the nature of the serosa tissue is used toadvantage for its ability to bond to like serosa tissue. The fundus 46of the greater curvature 44 forms the superior portion of the stomach43, and traps gas and air bubbles for burping. The esophageal tract 41enters the stomach 43 at an esophageal orifice below the superiorportion of the fundus 46, forming a cardiac notch 47 and an acute anglewith respect to the fundus 46 known as the Angle of His 57. The loweresophageal sphincter (LES) 48 is a discriminating sphincter able todistinguish between burping gas, liquids, and solids, and works inconjunction with the fundus 46 to burp. The gastroesophageal flap valve(GEFV) 49 includes a moveable portion and an opposing more stationaryportion. The moveable portion of the GEFV 49 is an approximately 180degree, semicircular, gastroesophageal flap 50 (alternatively referredto as a “normal moveable flap” or “moveable flap”) formed of tissue atthe intersection between the esophagus 41 and the stomach 43. Theopposing more stationary portion of the GEFV 49 comprises a portion ofthe lesser curvature 45 of the stomach 43 adjacent to its junction withthe esophagus 41. The gastroesophageal flap 50 of the GEFV 49principally comprises tissue adjacent to the fundus 46 portion of thestomach 43, is about 4 to 5 cm long (51) at it longest portion, and thelength may taper at its anterior and posterior ends. Thegastroesophageal flap 50 is partially held against the lesser curvature45 portion of the stomach 43 by the pressure differential between thestomach 43 and the thorax, and partially by the resiliency and theanatomical structure of the GEFV 49, thus providing the valvingfunction. The GEFV 49 is similar to a flutter valve, with thegastroesophageal flap 50 being flexible and closeable against the othermore stationary side.

The esophageal tract is controlled by an upper esophageal sphincter(UES)in the neck near the mouth for swallowing, and by the LES 48 andthe GEFV 49 at the stomach. The normal anti-reflux barrier is primarilyformed by the LES 48 and the GEFV 49 acting in concert to allow food andliquid to enter the stomach, and to considerably resist reflux ofstomach contents into the esophagus 41 past the gastroesophageal tissuejunction 52. Tissue aboral of the gastroesophageal tissue junction 52 isgenerally considered part of the stomach because the tissue protectedfrom stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of theesophagus and it is not protected from injury by prolonged exposure tostomach acid. At the gastroesophageal junction 52, the juncture of thestomach and esophageal tissues form a zigzag line, which is sometimesreferred to as the “Z-line.” For the purposes of these specifications,including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52.

FIG. 2 is a front cross-sectional view of anesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap 50 of the GEFV 49 (shown in dashed lines) and adeteriorated Grade III gastroesophageal flap 55 of the GEFV 49 (shown insolid lines). As previously mentioned, a principal reason forregurgitation associated with GERD is the mechanical failure of thedeteriorated (or reflux appearance) gastroesophageal flap 55 of the GEFV49 to close and seal against the higher pressure in the stomach. Due toreasons including lifestyle, a Grade I normal gastroesophageal flap 50of the GEFV 49 may deteriorate into a Grade III deterioratedgastroesophageal flap 55. The anatomical results of the deteriorationinclude moving a portion of the esophagus 41 that includes thegastroesophageal junction 52 and LES 48 toward the mouth, straighteningof the cardiac notch 47, and increasing the Angle of His 57. Thiseffectively reshapes the anatomy aboral of the gastroesophageal junction52 and forms a flattened fundus 56. The deteriorated gastroesophagealflap 55 illustrates a gastroesophageal flap valve 49 and cardiac notch47 that have both significantly degraded. Dr. Hill and colleaguesdeveloped a grading system to describe the appearance of the GEFV andthe likelihood that a patient will experience chronic acid reflux. L. D.Hill, et al., The gastroesophageal flap valve: in vitro and in vivoobservations, Gastrointestinal Endoscopy 1996:44:541-547. Under Dr.Hill's grading system, the normal movable flap 50 of the GEFV 49illustrates a Grade I flap valve that is the least likely to experiencereflux. The deteriorated gastroesophageal flap 55 of the GEFV 49illustrates a Grade III (almost Grade IV) flap valve. A Grade IV flapvalve is the most likely to experience reflux. Grades II and III reflectintermediate grades of deterioration and, as in the case of III, a highlikelihood of experiencing reflux. With the deteriorated GEFVrepresented by deteriorated gastroesophageal flap 55 and the fundus 46moved inferior, the stomach contents are presented a funnel-like openingdirecting the contents into the esophagus 41 and the greatest likelihoodof experiencing reflux. Disclosed subsequently is a device for restoringthe normal gastroesophageal flap valve anatomy, which device is oneembodiment of the present invention.

Referring now to FIG. 3, it is a perspective view of a fastener 100according to an embodiment of the invention. The fastener 100 generallyincludes a first member 102, a second member 104, and a connectingmember 106. As may be noted in FIG. 3, the first member 102 and secondmember 104 are substantially parallel and substantially perpendicular tothe connecting member 106 which connects the first member 102 to thesecond member 104.

The first and second members 102 and 104 are generally cylindrical. Eachhas a longitudinal axis 108 and 110 and a through channel 112 and 114along the longitudinal axes 108 and 110. The through channels 112 and114 are formed by through bores which are dimensioned to be slidinglyreceived on a tissue piercing deployment wire to be describedhereinafter.

The first member 102 also includes a first end 116 and a second end 118.Similarly, the second member 114 includes a first end 120 and a secondend 122. The first ends 116 and 120 form pointed dilation tips 124 and126, respectively. The dilation tips 124 and 126 are conical and moreparticularly take the shape of truncated cones. The pointed tips 129 and126 are pointed in opposite directions.

The first and second members 102 and 104 and the connecting 106 may beformed of different materials and have different textures. Thesematerials may include, for example, plastic materials such aspolypropylene, polyethylene, polyglycolic acid, polyurethane, or athermoplastic elastomer. As may be further noted in FIG. 3, theconnecting member 106 has a vertical dimension 128 and a horizontaldimension 130 which is transverse to the vertical dimension. Thehorizontal dimension is substantially less than the vertical dimensionto render the connecting member 106 readily bendable in a horizontalplane. The connecting member is further rendered bendable by the natureof the plastic material from which the fastener 100 is formed. Theconnecting member may be formed from either an elastic plastic or apermanently deformable plastic. An elastic material would preventcompression necrosis in some applications.

Referring now to FIG. 4, it illustrates another fastener 140 embodyingthe present invention. As with the fastener 100 of FIG. 3, the fastener140 includes a first member 142, a second member 144, and a connectingmember 146. The fastener 140 may be formed in one piece and a plasticmaterial similar to the fastener 100 of FIG. 3. The fasteners 100 and140 may be formed of a plastic material which includes a color pigment,for example pthalocyanine blue, for contrasting with the color of bodytissue to enable visualization of the fastener with an endoscope duringthe deployment of the fasteners. In addition, as may be seen in FIG. 4,the fastener 140 is impregnated with radio opaque material 148 so as torender the fastener 140 at least partially viewable under fluoroscopy.The radio opaque particles may be, for example, barium sulfate, bismuthsubcarbonate, tungsten powder or tantalum powder.

In addition to the foregoing, the second member 144 of the fastener 140includes a plurality of longitudinally spaced vertical slots 150. Thisrenders the second member 144 flexible in a direction opposite the slotsbut stiff in a direction of the slots. Hence, the second member 144 isresistant to bending in a first direction indicated by arrow 152 whilebeing substantially less resistant to bending in a direction indicatedby arrow 154. The reduced resistance to bending in the direction 154 ofthe second member 144 of the fastener 140 may be utilized to advantagein the deployment of the fastener 140.

Referring now to FIG. 5, it is a perspective view with portions cut awayof a fastener assembly embodying the present invention. The tissue layerportions above the fastener 162 have been shown cut away in FIGS. 5-9 toenable the deployment procedure to be seen more clearly. The assembly160 generally includes a fastener 162, a deployment wire 164, a pusher166, and a guide tube 168.

The fastener 162 takes the form of a further fastener embodiment of thepresent invention and includes a first member 172, a second member 174,and a connecting member 176. The fastener 162 differs from the fasteners100 and 140 of FIGS. 3 and 4, respectively, in that the second member174 is of solid construction and does not include a longitudinal throughchannel or a pointed tip. However, the first member 172 includes athrough channel as previously described and a pointed tip 178.

The first member 172 of the fastener 162 is slidingly received on thedeployment wire 164. The deployment wire 164 has a pointed tip 178 forpiercing the tissue layers 180 and 182 to be fastened together. As willbe seen hereinafter, and in accordance with further aspects of thepresent invention, the tissue layers 180 and 182 may be folded stomachtissue which are to be fastened and maintained together to form andmaintain a gastroesophageal flap valve.

As will be noted in FIG. 5, the tissue piercing wire 164, fastener 162,and the pusher 166 are all within the guide tube 168. The guide tube 168may take the form of a catheter, for example.

As will be further noted in FIG. 5, the second member 174 is disposedalong side the first member 172. This is rendered possible by theflexibility of the connecting member 176. Preferably, the first member,connecting member, and second member are arranged so that the connectingmember 176 lies to the side of the first member 172 and the secondmember 174.

With the first member 172 of the fastener 162 slidingly received on thetissue piercing wire 164 and with the pusher 166 just touching the firstmember 172 on the tissue piercing wire 164, the tip 178 of the tissuepiercing wire 164 pierces the tissue layers 180 and 182. The subassemblyof the tissue piercing wire 164, fastener 162, and pusher 166 may beguided to its intended location relative to the tissue layers 180 and182 by the guide tube 168. As will be seen hereinafter, this subassemblymay be alternatively guided by guide channels arranged to accommodatethe tissue piercing wire 164, fastener 162, pusher 166, and the guidetube 168.

Once the tissue piercing wire 164 has pierced the tissue layers 180 and182 to be fastened together, the pusher 166 may be utilized to push thefirst member 172 of the fastener 162 through the tissue layers 180 and182 on the tissue piercing wire 164. This is illustrated in FIG. 6. Asthe pusher 166 pushes the first member 172 through the tissue layers 180and 182, the connecting member 176 follows along beside and immediatelyadjacent to the first member 172 of the fastener 162 and the pusher 166.As may be seen in FIG. 7, the pusher 166 continues to push the firstmember 172 of the fastener 162 through the tissue layers 180 and 182 onthe tissue piercing wire 164 until the end 173 of the first member 172engaging the pusher 166 clears the second tissue layer 182. It may alsobe noted that at this time, the second member 174 of the fastener 162has engaged the surface 181 of tissue layer 180.

Referring now to FIG. 8, it will be seen that once the end 173 of thefirst member 172 has cleared the tissue layer 182, the tissue piercingwire 164 is then retracted within the pusher 166 to release the firstmember 172. The first member 172 being thus released from the tissuepiercing wire 164 will return to its original configurationsubstantially parallel to the second member 174 and substantiallyperpendicular to the connecting member 176. When the first member 172 isdeployed as shown in FIG. 8, the tissue piercing wire 164 and pusher 166may be withdrawn.

FIG. 9 illustrates the fastener 162 in its deployed position. It will benoted that the tissue layers 180 and 182 are fastened together betweenthe first member 172 of the fastener 162 and the second member 174 ofthe fastener 162. The connecting member 176 extends through the tissuelayers 180 and 182.

FIG. 10 is a perspective view with portions cut away of another fastenerand fastener assembly embodying the present invention in an early stageof deploying the fastener. The fastener 190 of FIG. 10 includes a firstmember 192, a second member 194, and a connecting member 196. Thefastener 190 is similar to the fastener 100 of FIG. 3 in that both thefirst member 192 and second member 194 includes a through bore. Thispermits the first member 192 and second member 194 to be slidinglyreceived in line with each other on the tissue piercing wire 164. Withboth the first member 192 and second member 194 being disposed on thetissue piercing wire 164, the second member 194 will not be deployeduntil after the tissue piercing wire 164 is retracted from the secondmember 194. As a result, the second member of the fastener 162illustrated in FIGS. 5-9 will deploy before the second member 194 offastener 190. However, the arrangement illustrated in FIG. 10 may beadvantageous where space is at a premium and the guide tube 168 has areduced diameter. The deployment of the fastener 190 by the tissuepiercing wire 164, the pusher 166, and the guide tube 168 is otherwisesimilar to the deployment procedure described above with respect toFIGS. 5-9.

FIG. 11 shows another fastener 200 embodying the present invention. Thefastener 200 is illustrated in an initial stage of deployment by thetissue piercing deployment wire 164, the pusher 166, and the guide tube168 to fasten tissue layers 180 and 182 together. FIG. 12 shows thefastener 200 after deployment fastening tissue layers 180 and 182together. The fastener 200 may be deployed as previously described inconnection with FIGS. 5-9.

The fastener 200 includes a first member 202, a second member 204, and aconnecting member 206. The connecting member 206 takes the form of abeaded chain and the second member is bifurcated at 208 to permit thesecond member 204 to be positioned between any pair of beads of theconnecting member 204. This renders the length of the connecting member206 between the first and second members 202 and 204 adjustable toaccommodate tissue layers of various densities and thicknesses.

FIG. 13 shows another fastener 210 embodying the present invention. Thefastener 210 is illustrated in an initial stage of deployment by thetissue piercing deployment wire 164, the pusher 166, and the guide tube168 to fasten tissue layers 180 and 182 together. FIG. 13A shows thefastener 210 in greater detail.

The fastener includes a first member 212, a second member 214, and aconnecting member 216. The first member 212, second member 214, andconnecting member 216 are integrally formed from a same tubular memberstock of material. The fastener 212 may be formed of plastic or metal,such as stainless steel or nitinol. As will be seen hereinafter, it ispreferred that the fastener 212, and all other fasteners embodying thepresent invention be formed of a material which is capable of returningto a desired shape or assuming a desired shape after being bent. Manyplastics and metals are capable of providing this function to render thefirst member 212 and second member 214 self-deployable for fastening thetissue layers 180 and 182.

As may be best seen in FIG. 13A, the connecting member 216 is formed ofa strip of a tubular member formed by a pair of longitudinalsubstantially parallel, substantially co-extensive cuts within thetubular body of the fastener 210. One such cut 218 is illustrated in thedrawing, and the other such cut is formed along the opposite side of thetubular body. The first member 212 and second member 214 are formed by asubstantially transverse circumferential cut 220 between thesubstantially parallel co-extensive cuts 218. The substantially parallelsubstantially co-extensive cuts 218 begin spaced from a first end 222 ofthe fastener 210 and terminates spaced from a second end 224 of a secondend. The first member 212 and second member 214 are thus tubular membersections between the circumferential cut 220 and the tubular memberfirst end 222 and second end 224. The fastener 210 still furtherincludes an elongated notch 226 extending from the second end 224 of thefastener 210 and extends towards the second end 222 substantiallydiametrically opposite and juxtaposed to a portion of the connectingmember 216. The notch 226 terminates proximal to the transversecircumferential cut 220.

The foregoing results in fastener 210 including a through channel 228within the first member 212 and a through channel 230 within the secondmember 214 to permit the fastener 210 to be slidingly received on thetissue piercing wire 164 as illustrated in FIG. 13. In addition, thefastener 210 at the first end 222 includes a pointed tip 232 which isformed by a sectioned portion of the tubular stock of the fastener 210.

As may be best seen in FIG. 13, when the fastener 210 is to be deployed,it is placed on the tissue piercing wire 164 with the first member 212and second member 214 in line with one another. The tissue piercing wire164 and fastener 210 are guided to their proper position adjacent tissuelayer 180. Next, the tissue piercing wire 164 is advanced to piercetissue layers 180 and 182 as illustrated in FIG. 13.

Next, as seen in FIG. 14, the pusher 166 is utilized to push thefastener 212 through the tissue layers 180 and 182 on the tissuepiercing wire 164. As depicted in FIG. 14, the end of the first member212 has just cleared the surface 181 of tissue layer 180.

Referring now to FIG. 15, when the pusher 166 pushes the fastener sothat the first member 212 is through the tissue layer 182, the firstmember 212 is free to deflect to a preformed configuration with respectto connecting member 216. The first member 212 deflects as shown in FIG.15 after the tissue piercing wire 164 is partially withdrawn asillustrated in FIG. 15. At this point, the second member 214 remains onthe tissue piercing wire 164 and has not deflected to its preshapedconfiguration.

As may be best seen in FIG. 16, a pusher 166 and most importantly theguide tube 168 are retracted to free the second member 214 to deflect toits preformed configuration. By virtue of the notch 226, the secondmember 214 is free to deflect as illustrated while on the tissuepiercing wire 164. As illustrated in FIG. 16, the fastener 210 is in itsdeployed configuration. The first member 212 self-deployed with thepartial retraction of the tissue piercing wire 164 and the second member214 self-deployed with a retraction of the guide tube 168. With thefastener 210 thus deployed, the tissue piercing wire 164, pusher 166,and guide tube 168 may be fully retracted. This is illustrated in FIG.17. As may be best seen in FIG. 17, the fastener 210 is deployed withthe first member 212 and second member 214 in contact with oppositesides of tissues 180 and 182 and with the connecting member 216extending between the first member 212 and second member 214 through thetissue layers 180 and 182. The shape memory material of the fastener 210also permits the connecting member 216 to be provided with a preshapedarcuate configuration as shown to cause the connecting members 212 and214 to securely fasten and pinch the tissue layers 180 and 182 together.

FIGS. 18-22 show another tissue fastening assembly 240 embodying thepresent invention. The assembly 240 includes the fastener 210 previouslydescribed with reference to FIG. 13A and the tissue fastening assemblyof FIGS. 13-16.

In addition to the fastener 210, the assembly 240 includes the tissuepiercing wire 164, the pusher 166, and a guide tube 368. The guide tube368 is similar to the guide tube 168 previously described. However, aguide tube 368 includes a slot 370 at its distal end 372. The slot 372,as will be seen subsequently, permits the second member 214 to assumeits deployed configuration before the first member 212 assumes itsdeployed configuration. FIG. 18 illustrates the assembly 240 in an earlystage of deploying the fastener 210. FIG. 19 shows the assembly 240wherein the tissue piercing wire 164 has been advanced to pierce thetissue layers 180 and 182 while the guide tube 368, the pusher 166, andthe fastener 210 are held stationary. With the tissue piercing wire 164piercing the tissue layers 180 and 182, the guide tube 368 may bepartially retracted so that the notch 370 is adjacent the second member214. By virtue of the notch 226, the second member 214 is permitted toassume its deployed configuration through the slot 370.

FIG. 20 illustrates the second member 214 of the fastener 210 in itsdeployed configuration within the slot 370. As will be noted in FIG. 20,the connecting member 216 is permitted to assume its preshapedconfiguration and the second member 214 is permitted to slide along thetissue piercing wire 164 within the notch 226. With the second member214 in its deployed configuration, the pusher 166 may now push the firstmember 212 through the tissue layers 180 and 182 on the tissue piercingwire 164.

FIG. 21 illustrates the fastener 210 with the first member 212 piercedthrough the tissue layers 180 and 182 and the second member 214 in itsdeployed configuration. The second member 214 is now against surface 181of tissue layer 180.

With the second member 214 first deployed, as may be seen in FIG. 22,the tissue piercing wire 164 may be partially retracted to free thefirst member 212 and to permit the first member 212 to assume itsdeployed configuration. At this point, the second member 214 is still onthe tissue piercing wire 164.

Now that both of the first and second members 212 and 214 respectivelyare deployed, the tissue piercing wire 164, pusher 160, and guide tube368 may be fully retracted to leave the fastener 210 in its deployedconfiguration.

FIG. 23 illustrates the fastener 210 in its deployed configuration afterthe tissue piercing wire 164, pusher 166, and guide tube 368 are fullyretracted. Again, the tissue layers 180 and 182 are securely fastenedtogether by the fastener 210 as previously described.

FIG. 24 is a perspective view of the fastener 210 imbedded within atissue layer 184 which is adjacent the tissue layer 180. Here it will beseen that the first member 212 of the fastener 210 is fully imbeddedwithin the tissue layer 184. The fastener 210 may be deployed asillustrated in FIG. 24 by any one of the methods previously describedwith respect to FIGS. 13-16 and FIGS. 18-22. Once the tissue piercingwire 164 is withdrawn to free the second member 212, the second member212 will become imbedded within the tissue 184. This illustrates theflexibility provided by the fasteners of the present invention for usewith varying types of tissue.

FIG. 25 is a perspective view with portions cut away of a furtherfastener 310 embodying the present invention in association with thetissue piercing wire 164, the pusher 166, and the guide tube 168 forfastening tissue layers 180 and 182 together. The fastener 310 includesa first member 312, a second member 314, and a connecting member 316.The fastener 310 is essentially identical to the fastener 210 previouslydescribed except that its notch 326 extends the entire longitudinallength of the second member 314. As a result, the second member 314 mayassume its deployed configuration off of the tissue piercing wire 164.In other words, when the second member 314 deploys, it will be, byvirtue of the continuous notch 326, free of the tissue piercing wire164. As a result, the tissue piercing wire 164 need not be fullyretracted to free the second member 314 from the tissue piercing wire164 after it has been deployed.

FIG. 26 is a side view, partly in cross-section, of another fastenerembodiment 410 of the invention. The fastener 410 includes a firstmember 412, a second member 414, and a connecting member which cannot beseen in the figure. One of the first and second members 412 and 414includes a restrictor or crimp 418. Here it may be seen that the secondmember 414 includes the crimp 418. The depth of the crimp 418 iscontrolled to exert a controlled amount of pressure against the tissuepiercing wire 164. The controlled pressure by the crimp 418 on thetissue piercing wire 164 provides controlled resistance to movementbetween the fastener 410 and the tissue piercing wire 164. This mayprovide a more “in control” feel between the fastener 410 and tissuepiercing wire 164 during the deployment of the fastener 410. It may alsobe noted in FIG. 26 that the deployment wire 164 has a bent or curvedtip 165. The bent tip 165 renders the development wire 164 steerable toaid in guiding the fastener to its intended location within the body.

Referring now to FIGS. 27-29, they illustrate a tissue fixation assembly500 which may utilize the fasteners and fastener deployment assembliespreviously described and embodying the present invention to advantage.Although the fasteners and deployment assemblies previously describedand embodying the present invention may be used in numerousapplications, the assembly 500 of FIGS. 27-29 is particularly configuredas a transoral gastroesophageal flap valve restoration device forrestoring a gastroesophageal flap valve.

With initial reference to FIG. 27, the device of FIG. 27 generallyincludes a longitudinal member 502 and a tissue shaper 504 carried atthe distal end of the longitudinal member 502. The tissue shaper 504 andlongitudinal member 502 are dimensioned for passing through theesophagus for transoral placement into a stomach.

The tissue shaper 504 includes a first arm 506 and a second arm 508. Thefirst arm 506 and second arm 508 are hingedly coupled together at ahinge point 510.

The first arm includes a fastener director 512. As will be seenhereinafter, stomach tissue layers to be fastened together may be shapedby the tissue shaper 504 by the first arm 506 and second arm 508confining the stomach tissue layers therebetween. The first arm 506 hasa tissue engaging surface 514. The first arm further includes aplurality of fastener directing channels 516. The fastener directlychannels 516 communicate with the tissue engaging surface 514. Each ofthe fastener directing channels 516 serves to direct a fastener into thetissue layers to be fastened together. Accordingly, the fastenerdirecting channels 516 are configured and dimensioned for receiving atissue fastener such as, for example, any one of the fastenerspreviously described herein and embodying the present invention.

The second arm 508 is a frame structure 518. The frame structure 518defines an opening 520 to permit the fasteners to be driven through thetissue layers while being held between the first arm 506 and second arm518.

The tissue shaper 504 further includes a tissue gripper 522. The tissuegripper 522 takes the form of a helical coil that grips the stomachtissue. As will be seen hereinafter, the tissue gripper is arranged topull the stomach tissue into and between the first and second arms 506and 508.

Referring now to FIG. 28, it illustrates the configuration of the device50 when shaping stomach tissue into a gastroesophageal flap valve. Hereit may be seen that the second arm 508 has been pivoted relative to thefirst arm 506. This permits stomach tissue pulled between the arms 506and 508 to be shaped as a gastroesophageal flap. FIG. 29 shows this ingreater detail. Here it may be seen that the tissue gripper 522 hasgripped stomach tissue 581 to form tissue layers 580 and 582 in theshape approximating a gastroesophageal flap. With the stomach tissue 581drawn into and between the first arm 506 and second arm 508 with thetissue engaging the tissue engaging surface 514, fasteners may now bedirected through the channels 516 and deployed for fastening stomachtissue layers 580 and 582 together. A plurality of channels 516 areprovided to enable a plurality of fasteners to be deployed.

In deploying the fasteners, the fastener directing channels 516 mayserve as guide tubes for guiding tissue piercing wires and pushers aspreviously described for deploying the fasteners. Alternatively,fastener guide tubes taking the form, for example, of guide tube 168previously described, may also be utilized and directed by the channels516 in the deployment of the fasteners.

Once the tissue layers 580 and 582 are fastened together, they will bemaintained in the folded configuration to approximate a gastroesophagealflap valve. The helical coil 522 may then be rotated to disengage fromthe tissue and the first and second arms 506 and 508 may be pivoted backto an in line configuration for retraction from the stomach andesophagus to complete the gastroesophageal flap valve restorationprocedure.

Because in this embodiment, the contacting tissue layers held by thefastener are both serosa tissue, the tissue layers will eventually growtogether. Hence, the fasteners of the present invention may be formed ofreabsorbable material which, after sufficient time to permit fusion ofthe tissue layers, will be absorbed by the body.

Referring now to FIGS. 30 and 31, they illustrate still another fastener600 according to an embodiment of the invention. The fastener 600generally includes a first member 602, a second member 604, and aconnecting member structure 606. As may be noted in FIGS. 30 and 31 theconnecting member structure includes a plurality of connecting members608 and 610. The connecting members 608 and 610 connect the first member602 to the second member 604.

The first member 602 is cylindrical and the second member 604 is acylindrical half-section. Each has a longitudinal through channel 612and 614. The through channel 614 is a through bore which is dimensionedto be a slidingly received on a tissue piercing deployment wire. Thechannel 614 is dimensioned to be optionally carried on the deploymentwire prior to deployment.

The first member 602 also includes a conical pointed tip 614.

The fastener 600 may be formed of any of the plastic or metal materialpreviously described. As may be further noted in FIGS. 30 and 31 theconnecting members 600 and 610 are relatively thin to render theconnecting member structure 606 readily bendable for ease of deployment.The connecting member structure is further rendered bendable of courseby the nature of the plastic or metal material from which the fastener600 is formed.

Referring now to FIGS. 32 and 33, they illustrate another fastener 700embodying the present invention. As with the previous fastener, thefastener 700 includes a cylindrical first member 702, cylindricalhalf-section 704 and a connecting member structure 706. The connectingmember structure 706 includes connecting members 708 and 710. Herehowever, the pointed tip 714 takes the form of a tapered section of thefirst member 702.

As in the previous embodiment the first member 702 of the fastener 700may be slidingly received on a deployment wire. The deployment wire maybe received by a bore 712. The fasteners 600 and 700 may be deployed aspreviously described.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

1-98. (canceled)
 99. A tissue fixation assembly comprising: a fastener,and a pair of hingedly coupled first and second arms for receiving thetissue therebetween, the first arm including a fastener director thatdirects the fastener into the tissue and the second arm including anopening permitting the fastener to be driven through the tissue whilebeing held between the first and second arms.
 100. The assembly of claim99 wherein the second arm is a frame structure.
 101. The assembly ofclaim 99 further comprising a tissue gripper that grips the tissue andpulls the tissue into and between the first and second arms.
 102. Theassembly of claim 99 wherein the first arm has a tissue engaging surfaceand wherein the fastener director includes a channel communicating withthe tissue engaging surface through which the fastener passes into thetissue.
 103. The assembly of claim 102 wherein the fastener directorincludes a plurality of the channels to direct a like plurality offasteners into the tissue.
 104. The assembly of claim 102 furthercomprising a fastener deployment wire extending through the channel andthat guides the fastener through the channel and into the tissue. 105.The assembly of claim 104 wherein the fastener comprises a first member,a second member, the first and second members having first and secondends, and a connecting member fixed to each of the first and secondmembers intermediate the first and second ends and extending between thefirst and second members, the first and second members beingsubstantially parallel to each other and separated by the connectingmember when the fastener is deployed, and one of the first and secondmembers having a longitudinal axis and a through channel along the axisarranged to be slidingly received on the fastener deployment wire. 106.A transoral gastroesophageal flap valve restoration device comprising: alongitudinal member, a portion of which is arranged for transoralplacement into a stomach; a fastener; and a tissue shaper carried on thelongitudinal member that shapes stomach tissue into a shape, the tissueshaper comprising a pair of hingedly coupled first and second arms forreceiving the stomach tissue therebetween, the first arm including afastener director that directs the fastener into the stomach tissue andthe second arm including an opening permitting the fastener to be driventhrough the stomach tissue while being held between the first and secondarms.
 107. The device of claim 106 wherein the second arm of the tissueshaper is a frame structure.
 108. The device of claim 106 wherein thetissue shaper further comprises a tissue gripper that grips the stomachtissue and pulls the stomach tissue into and between the first andsecond arms.
 109. The device of claim 106 wherein the first arm of thetissue shaper has a tissue engaging surface and wherein the fastenerdirector includes a channel communicating with the tissue engagingsurface through which the fastener passes into the stomach tissue. 110.The device of claim 109 wherein the fastener director includes aplurality of the channels to direct a like plurality of fasteners intothe stomach tissue.
 111. The device of claim 109 further comprising afastener deployment wire extending through the channel and that guidesthe fastener through the channel and into the stomach tissue.
 112. Thedevice of claim 111 wherein the fastener comprises a first member, asecond member, the first and second members having first and secondends, and a connecting member fixed to each of the first and secondmembers intermediate the first and second ends and extending between thefirst and second members, the first and second members beingsubstantially parallel to each other and separated by the connectingmember when the fastener is deployed, and one of the first and secondmembers having a longitudinal axis and a through channel along the axisarranged to be slidingly received on the fastener deployment wire.